Nicorette QuickMist 1mg/spray, Oromucosal Spray, Solution

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Mevcut itibaren:

JNTL Consumer Health I (Ireland) Limited Block 5, High Street, Tallaght, Dublin 24, , Ireland

ATC kodu:

N07BA01

INN (International Adı):

NICOTINE 1 µg/dose

Farmasötik formu:

OROMUCOSAL SPRAY

Kompozisyon:

NICOTINE 1 µg/dose

Reçete türü:

OTC

Terapötik alanı:

OTHER NERVOUS SYSTEM DRUGS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2012-12-03

Bilgilendirme broşürü

button
spray
nozzle
QuickMist 1mg/spray oromucosal spray, solution
Nicotine
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you.
-
Keep this leaflet. You may need to read it
again.
-
Ask your pharmacist if you need more
information or advice.
-
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to your doctor if you have not
been able to stop smoking after 6 months of
treatment with Nicorette QuickMist.
What is in this leaflet
1. What Nicorette QuickMist is and what it is
used for
2. What you need to know before you use
Nicorette QuickMist
3. How to use Nicorette QuickMist
4. Possible side effects
5. How to store Nicorette QuickMist
6. Contents of the pack and other information
1
WHAT NICORETTE QUICKMIST IS AND WHAT
IT IS USED FOR
Nicorette QuickMist is used to help you stop
smoking when you want to quit or to cut down
smoking before stopping completely. This is a
type of treatment called Nicotine Replacement
Therapy (NRT).
Nicorette QuickMist relieves nicotine withdrawal
symptoms including cravings, symptoms you get
when stopping smoking. When you suddenly
stop providing nicotine from tobacco to your
body, you get hit by different kinds of unpleasant
feelings called withdrawal symptoms. By using
Nicorette QuickMist you can prevent or reduce
these unpleasant feelings and cravings for
smoking. This is because you continue to
provide a small amount of nicotine to your body
for a short period of time. Nicorette QuickMist
does not contain the tar, carbon monoxide or
other toxins in cigarette smoke.
To improve the chances of helping you to stop
smoking, you should also seek counselling
advice and support, if you can.
2
BEFORE YOU USE
NICORETTE QUICKMIST
Do not use Nicorette QuickMist
-
If you

Ürün özellikleri

Version 11, Approved
SNAS 2506
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nicorette Quickmist 1mg/spray, oromucosal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One spray delivers 1 mg nicotine in 0.07 ml solution. 1 ml solution
contains 13.6 mg nicotine.
Excipient with known effect:
Ethanol 7.1 mg/spray
Propylene glycol 11 mg/spray
Butylated hydroxytoluene 363 ng/spray
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray, solution
A clear to weakly opalescent, colourless to light yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorette QuickMist is to be used for the treatment of tobacco
dependence in adults by relief of
nicotine withdrawal symptoms, including cravings, during a quit
attempt or to cut down smoking
before stopping completely. Permanent cessation of tobacco use is the
final objective. Nicorette
QuickMist should preferably be used in conjunction with a behavioral
support program.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Behavioural therapy advice and support will normally improve the
success rate.
_Adults and Elderly _
Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing
episode and do not exceed
64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period.
_Abrupt Smoking Cessation _
For Smokers willing and ready to stop smoking immediately.
Subjects should stop smoking completely during the course of treatment
with Nicorette QuickMist.
Page 2 of 10
The following chart lists the recommended usage schedule for the
oromucosal spray during full
treatment (Step I) and during tapering (Step II and Step III).
STEP I: WEEKS 1-6
Use 1 or 2 sprays when cigarettes normally would have been smoked or
if cravings emerge.
If after a single spray cravings are not controlled within a few
minutes, a second spray
should be used. If 2 sprays are required, future doses may be
delivered as 2 consecutive
sprays.
Most smokers will require 1-2 sprays every 30 minutes to 1 hour.
STEP II: W